K103582 is an FDA 510(k) clearance for the KELYNIAM CUSTOM SKULL IMPLANT (CSI). This device is classified as a Plate, Cranioplasty, Preformed, Non-alterable (Class II - Special Controls, product code GXN).
Submitted by Kelyniam Global, Inc. (New Britain, US). The FDA issued a Cleared decision on April 14, 2011, 127 days after receiving the submission on December 8, 2010.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5330.
| 510(k) Number | K103582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2010 |
| Decision Date | April 14, 2011 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXN - Plate, Cranioplasty, Preformed, Non-alterable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5330 |